
Article 1 
The active substance spinetoram, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2 

1. Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing spinetoram as an active substance by 31 December 2014.By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing spinetoram as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 June 2014 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.Following that determination Member States shall:
(a) in the case of a product containing spinetoram as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or
(b) in the case of a product containing spinetoram as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or those substances, whichever is the latest.
Article 3 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 13 February 2014.
For the Commission
The President
José Manuel BARROSO
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
SpinetoramCAS No 935545-74-7CIPAC No 802 
 XDE-175-J (Major factor)
(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione
 XDE_175-L (Minor factor)
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione ≥ 830 g/kg50-90 % XDE-175-J; and50-10 % XDE-175-LTolerance limits (g/kg):XDE-175-J = 581-810XDE-175-L = 83-270 1 July 2014 30 June 2024 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinetoram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:
((a)) the risk to aquatic and soil organisms;
((b)) the risk to non-target arthropods in-field;
((c)) the risk to bees during the application (overspray) and subsequently.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies.The applicant shall submit to the Commission, the Member States and the Authority the relevant information within 6 months after the adoption of pertinent guidance on the assessment of isomers.

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘67 SpinetoramCAS No 935545-74-7CIPAC No 802 
 XDE-175-J (Major factor)
(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione
 XDE_175-L (Minor factor)
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione ≥ 830 g/kg50-90 % XDE-175-J;and50-10 % XDE-175-LTolerance limits (g/kg):XDE-175-J = 581-810XDE-175-L = 83-270 1 July 2014 30 June 2024 For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinetoram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:
((a)) the risk to aquatic and soil organisms;
((b)) the risk to non-target arthropods in-field;
((c)) the risk to bees during the application (overspray) and subsequently.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies.The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 December 2014.’

